FDA WARNING_LETTER - ARKRAY Factory, Inc. - October 08, 2014

On March 4, 2015, the FDA issued a Warning Letter to Arkray Factory, Inc. following an inspection from October 6-8, 2014, in Shiga-Ken, Japan. The inspection found that the firm's Class II over-the-counter blood glucose monitoring devices, clinical HbA1c analyzers, and urinalysis reagent strips/analyzer systems were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to document CAPA activities and results (21 CFR 820.100(b))**: Investigations lacked complete documentation, cause determination, and corrective actions for issues like "b(4)" ReliOn blood glucose monitoring devices. The firm's response was inadequate, lacking evidence of retrospective review of CAPA records and documentation of identified deficiencies. 2. **Inadequate rework procedures (21 CFR 820.90(b)(2))**: Rework and acceptance activities were not fully documented in Device History Records (DHRs), with initial failed test results often omitted. The firm's response was insufficient, lacking evidence of retesting/reevaluation requirements in procedures and a retrospective DHR review. 3. **Failure to maintain complaint investigation records (